Comparison of Small Bowel Lesions Associated With Celecoxib Versus Ibuprofen Plus Omeprazole

Double-Blind, Placebo-Controlled, Randomized Two-Week Study, Comparing Small Bowel Lesions Associated With Celecoxib (200 mg BID) vs. Ibuprofen (800 mg TID) Plus Omeprazole (20 mg QD)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00640809

Enrollment

408

Registered

2008-03-21

Start date

2003-10-31

Completion date

2004-04-30

Last updated

2021-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Diseases, Inflammatory

Keywords

Bowel Disease

Brief summary

To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole

Interventions

DRUGCelecoxib

200 mg oral capsule twice daily for 2 weeks

OTHERPlacebo

Matched placebo for 2 weeks

DRUGIbuprofen plus Omeprazole

ibuprofen 800 mg oral tablet three times daily plus omeprazole 20 mg oral capsule once daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

Inclusion criteria: * Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data * No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine * Willing not to drink any alcohol during study period

Design outcomes

Primary

Measure	Time frame
Number of mucosal breaks in the small bowel for each subject	Day 30

Secondary

Measure	Time frame
Adverse events	Day 30
Laboratory tests	Day 30
Vital signs	Day 30
Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test	Day 30
Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks	Day 30
Change from screening visit in hemoglobin and hematocrit	Day 30
Total number of small bowel lesions with or without hemorrhage	Day 30
Physical examination	Day 30
Percentage of subjects with >=1 mucosal breaks	Day 30
Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)	Day 30
Change in Patient General Questionnaire Visual Analog Scale from Day 16	Day 30
Change in Severity of Dyspepsia Assessment questionnaire from Day 16	Day 30
Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks	Day 30

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026